Prolonged release bioadhesive therapeutic systems

Abstract

The present invention concerns a prolonged release bioadhesive mucosal therapeutic system containing at least one active principle, with an active principle dissolution test of more than 70% over 8 hours and to a method for its preparation. Said bioadhesive therapeutic system comprises quantities of natural proteins representing at least 50% by weight of active principle and at least 20% by weight of said tablet, between 10% and 20% of a hydrophilic polymer, and compression excipients, and comprising between 4% and 10% of an alkali metal alkylsulphate to reinforce the local availability of active principle and between 0.1% and 1% of a monohydrate sugar.

1 . a prolonged release bioadhesive therapeutic system containing at least one active principle comprising quantities of natural proteins representing at least 50% by weight of active principle and at least 20% by weight of said bioadhesive therapeutic system, between 10% and 20% of a hydrophilic polymer, compression excipients, and comprising between 3.5% and 10% of an alkali metal alkylsulphate.  
     
     
         2 . The bioadhesive therapeutic system according to  claim 1 , wherein said bioadhesive therapeutic system is a mucoadhesive tablet.  
     
     
         3 . A bioadhesive therapeutic system according to  claim 1 , wherein the alkali metal alkylsulphate is sodium laurylsulphate or diethylsulphosuccinate.  
     
     
         4 . The bioadhesive therapeutic system according to  claim 3 , in the form of a tablet in which the alkylsulphate is sodium laurylsulphate in a concentration of 3.5% to 10% of the total weight of the compounds in the tablet.  
     
     
         5 . The bioadhesive therapeutic system according to  claim 1 , in which the active principle is an antiviral that is active for herpes viruses, varicella zoster viruses, Epstein-Barr viruses or cytomegaloviruses.  
     
     
         6 . The bioadhesive therapeutic system according to  claim 5 , in which the active principle is an antiviral selected from the group of acyclovir, valaciclovir, zidovudine and ganciclovir.  
     
     
         7 . The bioadhesive therapeutic system according to  claim 6 , in which the active principle is acyclovir or valaciclovir present in an amount of 20 to 100 mg.  
     
     
         8 . The bioadhesive therapeutic system according to  claim 1 , in which the active principle is an antiviral active against human immunodeficiency virus.  
     
     
         9 . The bioadhesive therapeutic system according to  claim 1 , in which the active principle is an insoluble analgesic from the opioid family.  
     
     
         10 . The bioadhesive therapeutic system according to  claim 9 , in which the insoluble analgesic from the opioid family is fentanyl.  
     
     
         11 . The bioadhesive therapeutic system according to  claim 9 , in which the insoluble analgesic from the opioid family is fentyl insoluble base.  
     
     
         12 . The bioadhesive therapeutic system according to  claim 11 , in which the insoluble analgesic from the opioid family is present in an amount of 50 to 1,600 micrograms per bioadhesive therapeutic system.